National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 10) (PB 108 of 2020)

Administered by Department of Health, Disability and Ageing

Legislation au F2020L01359 Not in force Legislative Instrument

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  EXPLANATORY STATEMENT

 

National Health Act 1953

 

National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 10)

 

PB 108 of 2020

 

Authority

 

This instrument, made under subsection 85AB(1) of the National Health Act 1953 (the Act), amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) (the Principal Determination).

 

The Principal Determination provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).

 

Purpose

 

This instrument makes amendments to the Principal Determination.

 

The Act provides that PBS listed drugs may be assigned to formularies identified as F1 and F2. F1 is intended for single branded drugs and F2 for drugs that have multiple brands, or are in a therapeutic group with other drugs with multiple brands. Drugs on F2 are subject to the provisions of the Act relating to price disclosure and guarantee of supply.

 

Section 84AC of the Act provides that a drug is on F1 or F2 if there is a determination in force under section 85AB that the drug is on F1 or F2.

 

Subsection 85AB(1) of the Act empowers the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2.  For a drug to be on F1, it must satisfy the criteria in subsection 85AB(4). This requires that there are no listed brands of pharmaceutical items that have the drug that are bioequivalent or biosimilar, and no listed brands of pharmaceutical items that have another drug in the same therapeutic group as the first drug that are bioequivalent or biosimilar. It also requires that the drug was not on F2 the day before the determination comes into effect. A drug may only be determined to be on F2 if it does not satisfy one or more of the criteria for F1 (subsection 85AB(3)).

 

When subsection 85AB(5) of the Act applies, which relates to listed drugs with a single brand combination item on the PBS, the listed drug is not placed on F1 or F2, but on the administrative combination drug list.

 

This Instrument amends the Principal Determination by adding to F1 two new drugs methoxsalen and siponimod.  In addition, it also removes two drugs aurothiomalate and pneumococcal vaccine, polyvalent from F1 as these two drugs will no longer be PBS listed.

 

 

 

 

 

Variation and revocation

 

Unless there is an express power to revoke or vary PB 93 of 2010 cited in this Instrument, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 93 of 2010.

 

Consultation

 

This Instrument affects pharmaceutical companies with new medicines listing on the PBS. Methoxsalen and siponimod meet the criteria for F1 under subsection 85AB(4).  Aurothiomalate and pneumococcal vaccine, polyvalent are being removed from the PBS at the request of the responsible persons.

 

Before a drug is PBS listed and allocated to a formulary, there are detailed consultations about the drug with the responsible person and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of a submission made by the affected pharmaceutical company. Two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists.

 

No additional consultation with experts was undertaken regarding this determination because consultation with the affected responsible persons and the PBAC drew on the knowledge of persons with relevant expertise.

 

Commencement

 

This Instrument commences on 1 November 2020.

 

This Instrument constitutes a legislative instrument for the purpose of the
Legislation Act 2003.

 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Listed Drugs on F1 or F2) Amendment Determination 2020 (No. 10)
(PB 108 of 2020)

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Legislative Instrument

This Legislative Instrument is made pursuant to subsection 85AB(1) of the National Health Act 1953 (the Act), which relates to listed drugs on F1 or F2.  This Instrument amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) (the Principal Determination) which provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).

 

This Instrument amends the Principal Determination by adding to F1 two new drugs methoxsalen and siponimod.  In addition, it also removes two drugs aurothiomalate and pneumococcal vaccine, polyvalent from F1 as these two drugs will no longer be PBS listed.

 

Human rights implications

This Legislative Instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS assists with advancement of this human right by providing for subsidised access of medicines to patients. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Conclusion

This Legislative Instrument is compatible with human rights. Human rights continue to be protected by retaining clinically important medicines on the PBS and placing them in formularies that ensure the most cost effective pricing for supply of each medicine to Australians.

 

 

Paul Hansen

  Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

 

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2020 (No. 10) amends the National Health (Listed drugs on F1 or F2) Determination 2010, which pertains to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Enacted under the authority of the National Health Act 1953, this legislative instrument aims to update the list of drugs on the PBS by adding two new drugs, methoxsalen and siponimod, to the F1 formulary and removing aurothiomalate and pneumococcal vaccine, polyvalent from F1 as these drugs will no longer be listed on the PBS. The determination is made to ensure that the PBS formularies remain current and aligned with the evolving pharmaceutical landscape in Australia, facilitating access to necessary medications while maintaining cost-effectiveness. The changes are effective from 1 November 2020 and comply with human rights by promoting access to affordable healthcare, in accordance with international human rights instruments.

Scope and Application

The National Health (Listed Drugs on F1 or F2) Amendment Determination 2020 (No. 10) amends the National Health (Listed Drugs on F1 or F2) Determination 2010 under subsection 85AB(1) of the National Health Act 1953. This amendment pertains to the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS). The Act allows for PBS listed drugs to be assigned to F1 or F2 formularies, with F1 intended for single branded drugs and F2 for drugs that have multiple brands or are in a therapeutic group with other drugs with multiple brands. The amendment adds two new drugs, methoxsalen and siponimod, to F1 and removes aurothiomalate and pneumococcal vaccine, polyvalent from F1 due to their removal from the PBS listing. This instrument applies to pharmaceutical companies with new medicines being listed on the PBS and is relevant to the entities and drugs directly affected by these changes. The determination is applicable nationally, reflecting the Commonwealth's role in regulating the PBS, and is subject to the criteria specified in the National Health Act 1953. No specific exclusions or thresholds are mentioned in the text, but the process of determining placement in F1 or F2 involves detailed criteria and consultation with relevant stakeholders.

Key Provisions

The main operative sections of the National Health (Listed Drugs on F1 or F2) Amendment Determination 2020 (No. 10) involve the amendment of the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010), as detailed in section 1. Specifically, this amendment adds two new drugs, methoxsalen and siponimod, to the F1 formulary (section 2) and removes two existing drugs, aurothiomalate and pneumococcal vaccine, polyvalent, from F1 as these will no longer be listed on the Pharmaceutical Benefits Scheme (PBS) (section 3). The determination is made under the authority of subsection 85AB(1) of the National Health Act 1953 (the Act), which empowers the Minister (or delegate) to determine by legislative instrument that a listed drug is on F1 or F2 (section 4). The Act imposes certain obligations and requirements on the parties or entities it governs. Firstly, pharmaceutical companies must engage in detailed consultations with the responsible person and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) before a drug is listed on the PBS and allocated to a formulary (section 5). Methoxsalen and siponimod meet the criteria for F1 under subsection 85AB(4), ensuring that there are no listed brands of pharmaceutical items that have the drug that are bioequivalent or biosimilar, and no listed brands of pharmaceutical items that have another drug in the same therapeutic group as the first drug that are bioequivalent or biosimilar (section 6). Aurothiomalate and pneumococcal vaccine, polyvalent are being removed from the PBS at the request of the responsible persons (section 7). The determination does not specify any direct offences, penalties, or consequences for breach within the document. However, general provisions under the National Health Act 1953 and the Acts Interpretation Act 1901 provide for revocation or variation of the Principal Determination (section 8). Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 93 of 2010 unless there is an express power to do so (section 9). Furthermore, the determination is compatible with human rights and ensures that decisions about subsidised access to medicines on the PBS are evidence-based, thus protecting human rights by retaining clinically important medicines on the PBS (section 10).

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